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Model Number 7205326 |
Device Problem
Metal Shedding Debris (1804)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 12/30/2014 |
Event Type
malfunction
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Event Description
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During a shoulder arthroscopy utilizing the acromionizer,4.0 ep-1,dspl bl, it was reported that the burr shed metal pieces in the joint.Some could not be removed, and remained in the tissue.There were no reported patient injuries or complications.
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Manufacturer Narrative
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A review of the device history records and quality records associated with this manufactured lot confirm no abnormalities were reported with this product during manufacture.(b)(4).
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Search Alerts/Recalls
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